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CTRI Number  CTRI/2026/01/100880 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 11/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Dentistry
Other (Specify) [cordless gingival retraction ]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Gingival deflection using novel gingival retraction material. 
Scientific Title of Study   Comparative evaluation of gingival deflection using the novel cordless gingival retraction paste with three commercially available cordless gingival retraction pastes and nonimpregnated retraction cords: An in vivo study 
Trial Acronym  GGRETRACT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ABHIJIT ANIL TAMBE 
Designation  PhD SCHOLAR, PROFESSOR 
Affiliation  GDC and H,CHH SAMBHAJINAGAR 
Address  101, Department of prosthodontics and crown and bridge, SMBT Institute of Dental Sciences and Research, NANDI HILLS, DHAMANGAON,NASHIK
253, Department of prosthodontics and crown and bridge,GDC and H, Chh Sambhajinagar, Maharashtra.
Aurangabad
MAHARASHTRA
422403
India 
Phone  8180024424  
Fax    
Email  drabhijittambe24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishor Mahale 
Designation  Professor, PhD guide and HOD 
Affiliation  GDC and H,CHH SAMBHAJINAGAR 
Address  253, Department of prosthodontics and crown and bridge, GDC and H, Sambhajinagar
253, Department of prosthodontics and crown and bridge, GDC and H, Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India 
Phone  9823182550  
Fax    
Email  drkishorm@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  DRABHIJIT ANIL TAMBE 
Designation  PhD SCHOLAR, PROFESSOR 
Affiliation  GDC and H,CHH SAMBHAJINAGAR 
Address  101, Department of Prosthodontics and crown and bridge, SMBT Institute of Dental Sciences and Research, NANDI HILLS, DHAMANGAON,NASHIK
253, Department of Prosthodontics and crown and bridge, GDC and H, Chh Sambhajinagar, Maharshtra.
Aurangabad
MAHARASHTRA
422403
India 
Phone  8180024424  
Fax    
Email  drabhijittambe24@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pearls 32 and you Dental Clinic 
Address  202, Space cosmoc tower, Ashokstambh, Nashik, Maharashtra 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhijit Anil Tambe  SMBT Institute of Dental Science and Research, Nashik  101, Department of prosthodontics and crown and bridge, Nandi hills , Dhamangaon, Nashik.
Nashik
MAHARASHTRA 		 8180024424

drabhijittambe24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT IDSR, Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  requiring tooth preparation in maxillary anterior region  
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3 Commercially available other cordless gingival retraction pastes as comparator along with gold standard that is cord gingival retraction  Expasyl retraction system, 3M ESPE Retraction , Nocord retraction system And non-impregnated retraction cord. 
Intervention  Novel gingival retraction material   The novel gingival retraction paste will be placed into gingival sulcus of prepared tooth for 3-5 mins and then will be flushed out of oral cavity. The amount of gingival retraction gained will be recorded with into oral scan. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants aged 18 years and above Teeth requiring preparation for full coverage restoration Sound gingival and periodontal health of the abutment teeth.
Abutment teeth with normal size and contour (no developmental anomalies or regressive age-related changes)
Abutment teeth selected from the maxillary anterior region
 
 
ExclusionCriteria 
Details  Tipped, tilted, or rotated abutment teeth Presence of any gingival pathology Individuals with a thin gingival biotype
Diastema or restored anterior teeth Systemic diseases o
Known allergy to materials used
• Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The novel herbal cordless gingival retraction paste proposed in this protocol is designed to be biocompatible, cost-effective, and environmentally friendly, addressing limitations of existing commercial products. If the invitro and an inVivo results confirm adequate retraction and safety, this paste could provide a valuable alternative as gingival retraction material.

 		 Eligibility Check-Baseline
Baseline Pre intervention assessment, clinical photographs, randomization.
Intervention:
Group A: Novel gingival retraction material (Day 1)
Group B: Expasyl (Day 7)
Group C: 3M ESPE paste (Day 14)
Group D: No cord paste (Day 21)
Control Group: Non impregnated cord (Day 28)
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare and evaluate the efficacy of innovative herbal cordless gingival retraction
paste with the commercially available Expasyl retraction system.
2. To compare and evaluate the efficacy of innovative herbal cordless gingival retraction
paste with the commercially available Retraction M system.
3. To compare and evaluate the efficacy of innovative herbal cordless gingival retraction
paste with the commercially available Nocordretraction system.
4. To compare and evaluate the efficacy of innovative herbal cordless gingival retraction
paste with the commercially available non-impregnated retraction cord.
5. To compare the efficacy of innovative herbal cordless gingival retraction paste with the
three commercially available cordless retraction pastes and with non-impregnated
retraction cords. 		 Comparative analysis of amount of gingival retraction achieved by Novel cordless gingival retraction paste with 3 commercially available cordless retraction pastes and control as Non impregnated retraction cords.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="10" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  drabhijittambe24@gmail.com

  6. For how long will this data be available start date provided 09-10-2027 and end date provided 09-10-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim: To evaluate the efficacy of a novel herbal cordless gingival retraction paste in comparison with three different commercially available cordless retraction pastes and non-impregnated retraction cords.

Material and methods:

A two-phase experimental clinical study will be conducted. The study includes (1) formulation and invitro evaluation of a novel herbal cordless gingival retraction paste, (2) safety assessment via cytotoxicity assay on animal tissue, and (3) an InVivo comparison of gingival displacement efficacy among the novel paste, three commercial cordless pastes, and a non-impregnated retraction cord in 30 healthy adult participants. Gingival displacement will be measured using digital impressions and stereomicroscopic analysis. Statistical analysis will be performed using ANOVA and post hoc tests.

Results: The study will primarily focus on the formulation and in vitro evaluation of a novel gingival retraction paste, followed by animal studies to assess its safety and efficacy. Subsequently, a clinical trial will be conducted to compare gingival displacement among experimental and control groups. The mean gingival displacement for each participant will be recorded. The cross-sectional dimensions (buccolingual [BL] and mesiodistal [MD]) of each sample tooth on the model will be analyzed under a stereomicroscope to quantify gingival retraction.

Conclusion: This study aims to provide evidence for a novel, biocompatible, and cost-effective gingival retraction paste, potentially improving clinical outcomes and patient care.

 
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